Device Recall Indus Invue Screw Caddy

  • Modèle / numéro de série
    Lot Numbers: 7140.014; 6486.008  Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.
  • Description du dispositif
    Indus Invue Screw Caddy, Model: SI70097 || The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. || Recall expanded on 8/21/2013 to include additional lots of this product.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Société-mère du fabricant (2017)
  • Source
    USFDA